Status:
RECRUITING
PREHEVBRIO Pregnancy Outcomes Registry
Lead Sponsor:
VBI Vaccines Inc.
Conditions:
Vaccine Exposure During Pregnancy
Eligibility:
FEMALE
Brief Summary
The registry is an observational surveillance program designed to recruit and encourage participation of women who were exposed to PREHEVBRIO® hepatitis B vaccine during pregnancy and to collect and a...
Detailed Description
VBI Vaccines was granted a Biologic License by the FDA on 30 November 2021, to introduce PREHEVBRIO® in the United States for prevention of infection caused by all known subtypes of hepatitis B virus ...
Eligibility Criteria
Inclusion
- Pregnant woman who received PREHEVBRIO® vaccine within 28 days prior to conception or at any time during pregnancy. The time of conception will be calculated as the most reliable estimated date of delivery (EDD) minus 38 weeks. For this registry, gestational weeks will be estimated from the EDD or as corrected EDD, if a more reliable EDD (e.g., by ultrasound) is provided. If the EDD is not available or never estimated, the first day of the last menstrual period (LMP) will be used to estimate gestational age and EDD.
- The subject provided consent prior to enrollment (for eligible subjects under 18 years old, consent must be obtained from the subject's legally authorized representative).
- The subject documents agreement with the release of medical information and contact with her healthcare providers (e.g., PCP, obstetrician, nurse midwife) and the infant's healthcare provider (e.g., pediatrician) for the purpose of collecting medical information.
- Reporter's (participant and/or healthcare provider) contact information is available to allow for follow up.
Exclusion
- Subjects participating in another investigational device or drug study product within 28 days prior to conception or at any time during pregnancy.
Key Trial Info
Start Date :
November 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2032
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06097312
Start Date
November 30 2023
End Date
March 31 2032
Last Update
December 8 2023
Active Locations (1)
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1
ProPharma, Recruiting Nationwide
Overland Park, Kansas, United States, 66210